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The Daily Biotech Pulse: KaryoPharm's Selinexor Review Delayed, FDA Accepts Adamis Opioid Overdose Drug NDA

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 March 14)

  • Novartis AG (NYSE: NVS) (announced resignation of Sandoz generic unit's CEO Richard Francis, sparking speculation of a potential spin-off of the unit)
  • Array Biopharma Inc (NASDAQ: ARRY)
  • CareDx Inc (NASDAQ: CDNA)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Ionis Pharmaceuticals Inc (NASDAQ: IONS)
  • Kalvista Pharmaceuticals Inc (NASDAQ: KALV)(reported fiscal third-quarter results)
  • Millendo Therapeutics Inc (NASDAQ: MLND)

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 14)

  • Achaogen Inc (NASDAQ: AKAO)
  • ANCHIANO THERAP/S ADR (NASDAQ: ANCN)
  • Evogene Ltd (NASDAQ: EVGN)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Viveve Medical Inc (NASDAQ: VIVE)

Stock In Focus Karyopharm Says Regulatory Review For Multiple Myeloma Drug Extended By 3 Months

Karyopharm Therapeutics Inc (NASDAQ: KPTI) said the FDA has extended the PDUFA date for its NDA for Selinexor in combination with dexamethasone for treating patients with relapsed multiple myeloma who have received at least three prior therapies, by three months from April 6 to July 6.

Following the Feb. 26 Adcom meeting, the FDA panel voted 8 to 5, recommending that the FDA wait on the results from the company's Phase 3 BOSTON study before making a final decision. Subsequently, at FDA's request, the company submitted additional, existing clinical information as an amendment to the NDA, which prompted the 3-month extension.

With the announcement implying a likely decision by July as against expectation for a late 2019 or early 2020 date following the Adcom decision, the stock reacted positively.

The stock rallied 29.32 percent to $5.69 in after-hours trading.

Soleno Gets Nod From Safety Data Monitoring Committee For Genetic Disorder Drug Trial

Soleno Therapeutics Inc (NASDAQ: SLNO) said an independent Data Safety Monitoring Board has recommended the continuation of the company's Phase 3 study, dubbed DESTINY PWS trial, of a once-daily Diazoxide choline controlled-release tablet in Prader-Willi Syndrome patients, without any changes.

The company said it continues to enroll patients with 14 sites activated. Additionally, patients continue to roll over into C602, the 9-month open-label safety extension study for patients completing blinded treatment

The primary endpoint is a change from baseline hyperphagia score at Week 13.

The stock soared 22.96 percent to $1.66 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Adamis Says FDA Accepts Its NDA For Injectable Opioid Overdose Drug

Adamis Pharmaceuticals Corp (NASDAQ: ADMP) said the FDA has accepted for review its NDA for its higher naloxone injection product candidate for the treatment of opioid overdose. The PDUFA date has been set for Oct. 31.

The stock rallied 9.57 percent to $3.09 in after-hours trading.

Matinas To Offer Shares

Matinas BioPharma Holdings Inc (NYSE: MTNB) commenced an underwritten public offering of its common stock. All the shares are to be sold by the company.

The company said it would use the net proceeds from the offering, primarily for the ongoing development activities for its product candidates, namely MAT9001 and its lipid nano-crystal platform delivery technology, and for working capital, and other general corporate purposes.

View more earnings on IBB

The stock fell 10.83 percent to $1.07 in after-hours trading.

Earnings

Achieve Life Sciences Inc (NASDAQ: ACHV) reported a narrower loss of 55 cents per share compared to a loss of $3.17 per share in the year-ago quarter. Analysts had expected a loss of 64 cents per share. As of Dec. 31, 2018, cash, cash equivalents, short-term investments and restricted cash were $14.7 million.

The stock skyrocketed 72.65 percent to $1.78 in after-hours trading.

Novelion Therapeutics Inc (NASDAQ: NVLN) reported net revenues climbed from $38.91 million in the fourth quarter of 2017 to $40.71 million in the fourth quarter of 2018. This compared to the $40.9 million consensus estimate. The net loss per share for the quarter narrowed from $1.32 to $1.03.

For 2019, the company expects net revenues of $160 million to $175 million, ahead of the $130.6 million consensus estimate.

The stock jumped 24.59 percent to $1.52 in after-hours trading.

BioTime, Inc. (NYSE: BTX)'s fourth-quarter revenues declined $0.2 million year-over-year to $0.8 million. However, the net loss narrowed from 58 cents to 35 cents. Analysts had expected a narrower loss of 7 cents per share.

The stock plunged 19.35 percent to $1.25 in after-hours trading.

RA Medical Systems Inc (NYSE: RMED) reported a year-over-year increase in revenues from $1.9 million to $2 million. However, the net loss per share widened from 40 cents to $1.18. Analysts expected a loss of 38 cents per share.

For the first quarter, the company expected total revenues of $1 million to $1.4 million, below the $4.3 million consensus estimate.

The stock declined 23.90 percent in after-hours trading.

On The Radar Earnings

Diplomat Pharmacy Inc (NYSE: DPLO) Q4 Adj. EPS $0.13 Misses $0.23 Estimate

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