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The Daily Biotech Pulse: FDA Panel Vote Sinks KaryoPharm, Refuse-To-file Letter For Adamis, Tandem Diabetes Earnings

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Feb. 26)

  • AstraZeneca plc (NYSE: AZN)(announced positive results for a Phase 3 study of its Lynparza in pancreatic cancer, with a mutated BRCA gene
  • Eli Lilly And Co (NYSE: LLY)
  • argenx SE – ADR (NASDAQ: ARGX)
  • Cerecor Inc (NASDAQ: CERC)
  • Eton Pharmaceuticals Inc (NASDAQ: ETON)
  • Homology Medicines Inc (NASDAQ: FIXX)
  • Millendo Therapeutics Inc (NASDAQ: MLND
  • Merck & Co., Inc. (NYSE: MRK)
  • Moderna Inc (NASDAQ: MRNA)
  • Veracyte Inc (NASDAQ: VCYT) (reported better-than-expected fourth-quarter results)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Feb. 26)

  • ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
  • VERONA PHARMA P/S ADR (NASDAQ: VRNA)

Stock In Focus FDA Panel Votes For Delaying Approval Of KaryoPharm's Multiple Myeloma Drug

Karyopharm Therapeutics Inc (NASDAQ: KPTI) said FDA's Oncologic Drug Advisory Committee that discussed its NDA for selinexor, used in combination with dexamethasone, for treating relapsed refractory multiple myeloma, voted 8-5 recommending the FDA wait for results from a Phase 3 study dubbed BOSTON before making a final decision regarding approval.

The BOSTON study is evaluating selinexor in combination with Velcade and low-dose dexamethasone compared to bortezomib and low-dose dexamethasone in patients with multiple myeloma who have had one to three prior lines of therapy.

Top-line data from the study is expected by the end of 2019 or into 2020.

The stock slumped 19.71 percent to $3.91 in after-hours trading.

Synergy Pharma Sells Certain Of Its Assets To Bausch

Synergy Pharmaceuticals Inc (NASDAQ: SGYP) said Bausch Health Companies Inc (NYSE: BHC) has emerged as the successful bidder to acquire certain of its assets, including its constipation drug Trulance, for about $195 million and the assumption of certain assume liabilities.

Synergy had filed for a voluntary Chapter 11 bankruptcy protection in Dec. 2018. The hearing for approving the sale is scheduled for March 1.

Penny stock Synergy soared 84.52 percent to 3.11 cents in after-hours trading.

Alder BioPharma To Offer Shares

Alder Biopharmaceuticals Inc (NASDAQ: ALDR) said it intends to offer up to $105 million worth of shares in an underwritten public offering. Concurrently, the company also intends to privately place up to $20 million shares to certain institutional and other accredited investors affiliated with, or managed by, Redmile Group at the same price as that the price of the public offering.

The shares fell 2.52 percent to $13.17 in after-hours trading.

Adamis NDA For Erectile Dysfunction Drug Shot Down By FDA

Adamis Pharmaceuticals Corp (NASDAQ: ADMP) said it has received a Refuse to File letter from the FDA regarding its NDA for sublingual tadalafil product, its treatment candidate for erectile dysfunction. The company had submitted the NDA for the pipeline asset Dec. 28.

The stock plunged 13.04 percent to $2.80 in after-hours trading.

The FDA has sought longer real-time stability data and additional dissolution data for both clinical and registration batches.

See Also: Exact Sciences A 'Must-Own' Growth Stock, Goldman Sachs Says In Upgrade

Earnings

Tandem Diabetes Care Inc (NASDAQ: TNDM) announced its CEO Kim Blickenstaff will transition to the newly-created position of Executive Chairman of the board and that COO John Sheridan will be elevated to the role of CEO.

Separately, the company reported fourth-quarter sales of $76.2 million, higher than $40.29 million last year. The company reversed to a profit of 2 cents per share from a loss of $1.23 per share a year ago. For 2019, the company expects sales of $255 million to $270 million. The fourth-quarter results exceeded estimates and the 2019 revenues guidance was also ahead of expectation.

The stock rallied 19.61 percent to $59.10 in after-hours trading.

View more earnings on XBI

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) reported Dec. quarter revenues of $6.7 million compared to $4 million in the year-ago period, while analysts estimated revenues of $5.35 million. The loss per share remained flat at 20 cents per share. The company also said it is now moving to a Jan. 1 fiscal year.

The stock advanced 9.22 percent to $166.99 in after-hours trading.

Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) reported fourth-quarter non-GAAP adjusted EPS of $3.64 on revenues of $476.46 million. In comparison, non-GAAP adjusted EPS and revenues were $2.95 and $436.40 million, respectively, last year. The results beat expectations.

The company guided 2019 revenues to $2.05 billion to $2.13 billion and non-GAAP adjusted EPS of $14.30-$15. The guidance exceeded expectations.

The stock added 8.02 percent to $138 in after-hours trading.

Mylan NV (NASDAQ: MYL) reported fourth-quarter revenues of $3.08 billion, down 5 percent year-over-year, and adjusted EPS of $1.30, down 9 percent. The revenues were in line but the bottom-line result trailed expectation.

For 2019, the company expects revenues of $11.50 billion to $12.50 billion and adjusted EPS of $3.80-$4.80, below the consensus estimate of $5.04.

The stock fell 9.70 percent to $27.65 in after-hours trading.

Inogen Inc (NASDAQ: INGN)'s fourth-quarter revenues climbed 35.7 percent to $86.5 million. The company reversed to a profit of 44 cents per share on an adjusted basis from a loss of 3 cents a year ago.

Inogen reiterated its full-year revenue guidance of $430 million to $440 million but lowered its GAAP net income guidance.

The company also said it expects net positive cash flow for 2019, with no additional equity capital required to meet its current operating plan.

The stock slipped 9.34 percent to $126.98 in after-hours trading.

On The Radar Clinical Trial Results

Along with its financial results, Sarepta will also release Phase 1/2 data for its Duchenne muscular dystrophy candidate MYO-101.

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