On June 14, 2017, Tetraphase Pharmaceuticals, Inc. (the “Company”) and Patheon UK Limited and certain of its affiliates (collectively, “Patheon”) entered into a Master Manufacturing Services Agreement (the “Master Agreement”). Under the Master Agreement, the Company is responsible for supplying the active pharmaceutical ingredient for eravacycline to Patheon, and Patheon is responsible for manufacturing eravacycline, conducting quality control, quality assurance, analytical testing and stability testing and packaging. The Company expects to enter into two related Product Agreements (each a “Product Agreement”) pursuant to the Master Agreement to govern the terms and conditions of Patheon’s manufacture of commercial supplies of eravacycline, the Company’s lead product candidate, at Patheon’s Greenville, North Carolina and Ferentino, Italy manufacturing sites. Each Product Agreement that the Company may enter into from time to time will be governed by the terms of the Master Agreement, unless expressly modified in such Product Agreement. Pursuant to the Master Agreement, the Company has agreed to order from Patheon at least a certain percentage of its annual commercial requirements for eravacycline in the United States and European Union each year for the term of the Master Agreement. The Master Agreement has an initial term ending December 31, 2022, and will automatically renew after the initial term for successive terms of two years each, unless either party gives notice of its intention to terminate the Master Agreement at least 18 months prior to the end of the then current term. The Company may terminate a Product Agreement upon 30 days’ prior written notice if any governmental agency takes any action that prevents the Company from importing, exporting, purchasing or selling eravacycline. Either party may terminate the Master Agreement or a Product Agreement (a) upon written notice if the other party has failed to remedy a material breach under the Master Agreement or a Product Agreement within a specified time following receipt of written notice of such breach, and (b) immediately upon written notice to the other party in the event that the other party is declared insolvent or bankrupt, a voluntary petition of bankruptcy is filed in any court by such other party or the Master Agreement or a Product Agreement is assigned by such other party for the benefit of creditors. Patheon may terminate the Master Agreement or a Product Agreement upon six months written notice if the Company assigns the Master Agreement to an assignee that, in the opinion of Patheon acting reasonably, is (i) not a creditworthy substitute for the Company, or (ii) a competitor of Patheon. The Master Agreement contains, among other provisions, customary representations and warranties by the parties, a grant to Patheon of certain limited license rights to the Company’s intellectual property in connection with Patheon’s performance of the services under the Master Agreement, certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions. The foregoing description of the material terms of the Master Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Master Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2017. The Company intends to seek confidential treatment for certain portions of the Master Agreement pursuant to a Confidential Treatment Request submitted to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
Entering into a manufacturing agreement? 2 years before the drug will even be approved?? Assuming it will even be approved?? Way way too early for this agreement. The news is nonsense
To the moon
FORM 4 [ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b). UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES
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Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934 or Section 30(h) of the Investment Company Act of 1940
1. Name and Address of Reporting Person * Horn Patrick Taylor 2. Issuer Name and Ticker or Trading Symbol TETRAPHASE PHARMACEUTICALS INC [ TTPH ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable) _____ Director _____ 10% Owner __ X __ Officer (give title below) _____ Other (specify below) Chief Medical Officer (Last) (First) (Middle) 480 ARSENAL ST. SUITE 110 3. Date of Earliest Transaction (MM/DD/YYYY) 6/13/2017 (Street) WATERTOWN, MA 02472 (City) (State) (Zip) 4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line) _ X _ Form filed by One Reporting Person ___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned 1.Title of Security (Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code (Instr. 8) 4. Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4) Code V Amount (A) or (D) Price Common Stock 6/13/2017 M 10000 A $2.03 10000 D
Table II - Derivative Securities Beneficially Owned ( e.g. , puts, calls, warrants, options, convertible securities) 1. Title of Derivate Security (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Trans. Date 3A. Deemed Execution Date, if any 4. Trans. Code (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date 7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4) 8. Price of Derivative Security (Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4) Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares Employee Stock Option (right to buy) $2.03 6/13/2017 M 10000 (1) 1/2/2021 Common Stock 10000 $0.00 47689 D Explanation of Responses: (1) This option is fully vested.
Reporting Owners Reporting Owner Name / Address Relationships Director 10% Owner Officer Other Horn Patrick Taylor 480 ARSENAL ST. SUITE 110 WATERTOWN, MA 02472
Chief Medical Officer
Signatures /s/Maria Stahl as Attorney-in-Fact for Patrick Horn 6/14/2017 ** Signature of Reporting Person Date
X axis : Stocks Price Correlation Coefficient Y axis : Quantity of stocks Sep-2016 1,000 Day Parameter 2,830 NASDAQ Stocks Price Analysis This stock mode of correlation coefficient is -0.5 In other words, the correlation coefficient of the other stoc
From form Q 10 for 1st Qt report 2017: " In the third quarter of 2017, we plan to submit a marketing authorization application, or MAA, to the European Medicines Agency for IV eravacycline for the treatment of cIAI. We expect the MAA submission will be supported by data from IGNITE1."
Another key mile stone next quarter - interesting - only need one study in Europe?
Anyone knows what happened to the lawsuit brought by a graduate student of the Harvard chemist founder of this company against his former advisor? I wonder if it's still going on now that the compound is inferior to a generic drug!
From abstracts presented at ASM: “Additional data presented at ASM Microbe on these two compounds confirm potent preclinical activity seen previously, particularly against Gram-negative pathogens. For TP-6076, the MIC90values reported were as much as 64-fold lower than those for tigecycline against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii."
Very nice back ups.
June price movement is unpredictable, but July will follow the results of announced P3 results. Given the income stream expected from approval of NDA the price is predictably in the $20+ area. Soon rational minds could began discounting the future price by the probability of success (put at 75% probability by some- but I think higher) of current P3 (IGNITE 4) against expected income from such sales. That would justify a considerably higher value. Of course, that value hardly considers the pipeline and legal rights to the synthetic manufacturing ability. But that value will be added once an approved drug is on the market, which again pushes the price far higher. Best to climb aboard soon.
To understand the probability of success in passing the new P3 you must consider the following: looking at Ignite 1 the drug was more than 95% overall successful in treating CIAI. To pass it needed to only beat the 10% inferior standard to ertapenem . The new standard to pass IGNITE 4 it must beat a 12.5% inferior standard to meropenem. That means it can likely be less than 87.5% overall effective and still pass as it's comparator will never hit 100% cure rate (assuming it even can beat eravacycline). While it's hard to say anything can have a 100% probability in passing such a test, ... but....
Volume 1K -- no trades since 9:30
These trials are going nowhere. Down 5%. Now you understand?
buying AXSM at $3.80 is like buying JAZZ at $1 a few years ago now trading at $151 (AXSM) Market Cap $85 M/Cash $55 M / 5x BIG Phase 3 programs in various indications targeting large Markets with first results in Q3 2017 =20 BAGGER ..FANTASTIC OPPORTUNITY !
Undiscovered and massive undervalued Biotech Stock with lots of Big News on the way.This Stock is brutally undervalued with a Market cap of just $85 million and $55 million in cash .Founder and Ceo is the larget shareholder holding over 7 million shares (30%) more than 50% of O/S is owned by Insider and Institutions which is a great sign .
This undiscovered stock could be the next 10 bagger gem if just one of their 5 ongoing Phase 3 programs is successful .GL
Market-Cap: $85 Million Cash: $55 Million(cash runway into the first quarter of 2019.) Price:$3.80
Shares Out: 23.5 Million
Aegis Capital has reiterated a ‘Buy’ rating and price target of $20 on Axsome Therapeutics (NASDAQ: AXSM) after the company reported financial results for the quarter ended March 31, 2017. The analyst noted that although Axsome reported revenue in-line with consensus estimates, the focus remains on upcoming catalysts such as the company’s ongoing clinical trials. Since February 2017, the company’s AXS-05 has received fast track designation from the FDA for the treatment of Alzheimer’s disease (AD) agitation and treatment resistant depression (TRD). Topline data from the TRD treatment study is expected in the first quarter of 2018. Additionally, Axsome is developing AXS-02 in three separate phase 3 clinical programs, including chronic low back pain associated with modic changes and complex regional pain syndrome, with interim data expected in the fourth quarter of 2017, as well as knee osteoarthritis associated with bone marrow lesions, with interim data expected in the third quarter of 2017.
Good news?? Stock down 5%. Maybe not?
Time to add :)
I still think the stock will be below 4 by end of June
Will definitely close below $6 today. Definitely
To support 30 days to readout of P3 for CIAI note the following; full enrollment was announced 51 days ago, which means treatment was completed 7 days later. Proof of cure occurs 30 days after first treatment. So the wild card is how long the Data Committee needs to complete review. Assuming 60 days to review, suggest results in 30 days!! The company says top line read out in third quarter! Like July 1