Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peak
(Biotech stocks hitting 52-week highs on Nov. 1)
- Gritstone Oncology Inc (NASDAQ: GRTS)
- Repligen Corporation (NASDAQ: RGEN)(reported higher revenues and adjusted earnings for Q3)
- Zoetis Inc (NYSE: ZTS)(reported beat-and-raise Q3)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Nov. 1)
- Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) (made its Nasdaq debut)
- Magenta Therapeutics Inc (NASDAQ: MGTA)
- MOTIF BIO PLC/S ADR (NASDAQ: MTFB)
- Presbia PLC (NASDAQ: LENS)
- SUMMIT THERAPEU/S ADR (NASDAQ: SMMT)
- Urovant Sciences Ltd (NASDAQ: UROV)(reported positive results from the international Phase 2b study of vibegron, a pipeline candidate being evaluated for treating adults with symptoms of overreactive bladder)
Stocks In Focus Illumina to Buy Pacific Biosciences
Pacific Biosciences of California (NASDAQ: PACB) and Illumina, Inc. (NASDAQ: ILMN) announced an agreement under which the latter would buy the former for $8 per share in cash, a 77 percent premium to Pacific Biosciences' closing price Thursday.
Separately, Pacific Biosciences announced a decline in Q3 revenues from $23.5 million a year ago to $18.2 million. The loss per share stayed put at 19 cents per share, wider than the 15 cents per share loss expected by analysts. The company attributed the revenue decline to some customers holding back in purchasing products in anticipation of the new products the company launched recently or has announced plans of launch early next year.
The stock skyrocketed 66.52 percent to $7.51 in after-hours trading.
FDA Panel Votes Against Approval of Alkermes' Drug For Major Depressive Disorder
Alkermes Plc (NASDAQ: ALKS) said a joint committee of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee that evaluated its NDA for ALKS 5461, an investigational treatment for major depressive disorder, voted against approval of the drug by a 21-2 margin.
The PDUFA date for the candidate is set for Jan. 31, 2019.
The stock fell 5.71 percent to $38.50 in after-hours trading.
Adverum Biotech To Discontinue Gene Therapy Study for Protein Deficiency Disorder
Adverum Biotechnologies Inc (NASDAQ: ADVM) said it has decided to discontinue the development of ADVM-043, an investigational AVVrh 10-based gene therapy to treat Alpha-1 Antitrypsin, or A1AT, deficiency. The decision was based on the review of Phase 1/2 data, which did not demonstrate the potential to reach M-protein threshold levels of 11µM.
The stock slumped 34.07 percent to $3 in after-hours trading.
Final Decision by FDA Not Yet Made on Histogenics' Neocart BLA
Following the Type C meeting Histogenics Corp (NASDAQ: HSGX) held with the FDA, the company said it continues to discuss with the regulatory body the clinical data generated to-date for its Neocart, the potential need for any additional supplemental clinical data, either longer-term data from the ongoing Phase 3 trial or additional studies, and potential regulatory pathways for the BLA to be accepted.
Neocart is an investigational cartilage tissue implant to treat certain knee cartilage injuries.
The company said it would provide further update on its negotiations with the FDA by the end of November.
The stock fell 11.80 percent to $0.59 in after-hours trading.
OvaScience Revises Exchange Rate For Merger With Millendo; Secures Additional Financing
OvaScience Inc (NASDAQ: OVAS) said it has updated the terms of the previously announced merger agreement with Millendo Therapeutics, a privately-held company focusing on therapies for orphan endocrine diseases. The companies also increased the size of the associated financing.
The increased financing as well as the $37 million in net cash from OvaScience render the total proceeds of the merger and financing at $87 million, which would be used to fund the further development of Millendo's lead assets.
The exchange rate for the merger is revised, giving OvaScience shareholders with a post-money valuation of $246 million. OvaScience shareholders will own about 17 percent of the combined company, current Millendo shareholders 63 percent and investors participating in the financing the remaining 20 percent.
The merger is expected to close in Q4 2018.
The stock soared 18.55 percent to $0.80 in after-hours trading.
Exelixis, Inc. (NASDAQ: EXEL) reported roughly 48 percent revenue growth for its Q3, while its earnings of 41 cents per share came in well ahead of the 19 cents per share expected by analysts.
The stock rallied 13.04 percent to $16.90 in after-hours trading.
TESARO Inc (NASDAQ: TSRO) reported total revenues of $64.4 million, down from $142.8 million reported for last year, which included collaboration revenues of $101 million. Net product sales rose from $41.8 to $63.6 million.
The net loss of $2.49 per share was narrower the consensus loss estimate of $2.55 per share.
The stock advanced 7.43 percent to $34.25 in after-hours trading.
Puma Biotechnology Inc (NASDAQ: PBYI)'s Q3 net revenues came in at $52.6 million compared to $6.1 million a year ago. The net loss per share narrowed from $2.07 to 37 cents. The consensus had called for a loss of 97 cents per share.
The negative stock reaction was apparently due to modest sequential growth in sales of its breast cancer drug Nerlynx.
The stock plunged 32.93 percent to $25.89 in after-hours trading.
T2 Biosystems Inc (NASDAQ: TTOO) reported strong Q3 revenue growth and a narrower than expected loss, while it reiterated its full-year guidance.
The stock jumped 7.01 percent to $5.65 in after-hours trading.
On The Radar Earnings
AbbVie Inc (NYSE: ABBV) Q3 Adj. EPS $2.14 Beats $2.01 Estimate, Sales $8.24B Beat $8.22B Estimate
ImmunoGen, Inc. (NASDAQ: IMGN) Q3 EPS $(0.32) Misses $(0.31) Estimate, Sales $10.928M Miss $13.84M Estimate
Obalon Therapeutics Inc (NASDAQ: OBLN) (before the market open)
CytRx Corporation (NASDAQ: CYTR) (before the market open)
The FDA will rule on Trevena Inc (NASDAQ: TRVN)'s NDA for Oliceridine to treat moderate to severe acute pain. FDA's Anesthetic and Analgesic Drug Products Advisory Committee, which met Oct. 11 to review the NDA, voted 8 against and 7 in favor of approving Oliceridine.
A joint committee of Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss the efficacy, safety, and benefit-risk profile of SAGE Therapeutics Inc (NASDAQ: SAGE)'s brexanolone 5 mg/mL intravenous injection, tested for postpartum depression.
See more from Benzinga
- Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates
- The Daily Biotech Pulse: AbbVie's Leukemia Drug Trial Meets Endpoint, Denali Strikes Collaboration Deal
- The Daily Biotech Pulse: KemPharm, FDA Nod For Merck, Clovis Q3 Miss, 3 Stocks To Debut
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