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The Daily Biotech Pulse: FDA Approves Baudax Bio's Non-Opioid Pain Drug, Aerie Rallies On Q4 Results, D-Day For Esperion

Shanthi Rexaline

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

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Feb. 20.)

  • Akebia Therapeutics Inc (NASDAQ: AKBA)
  • Aptose Biosciences Inc (NASDAQ: APTO)
  • Arcturus Therapeutics Ltd (NASDAQ: ARCT)
  • Arcus Biosciences Inc (NYSE: RCUS)
  • BELLUS Health Inc (NASDAQ: BLU)
  • Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)
  • Calithera Biosciences Inc (NASDAQ: CALA)
  • Cue Biopharma Inc (NASDAQ: CUE)
  • DexCom, Inc. (NASDAQ: DXCM)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • GENMAB A/S/S ADR (NASDAQ: GMAB)
  • Grifols SA - ADR ADR Class B (NASDAQ: GRFS)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Masimo Corporation (NASDAQ: MASI) (announced its fourth-quarter results)
  • Medpace Holdings Inc (NASDAQ: MEDP)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
  • Relmada Therapeutics Inc (NASDAQ: RLMD)
  • Repro-Med Systems, Inc. (NASDAQ: KRMD)
  • Revance Therapeutics Inc (NASDAQ: RVNC) (announced $287.5-million debt offering)
  • Revolution Medicines Inc (NASDAQ: RVMD) (went public Feb. 13)
  • Scpharmaceuticals Inc (NASDAQ: SCPH)
  • Soligenix, Inc. Common Stock (NASDAQ: SNGX)
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
  • Syneos Health Inc (NASDAQ: SYNH) (reacted to fourth-quarter results)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM)
  • Zai Lab Ltd (NASDAQ: ZLAB)

Down In The Dumps

(Biotech stocks that hit 52-week lows Feb. 20.)

  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)
  • Arca Biopharma Inc (NASDAQ: ABIO)
  • CASI Pharmaceuticals Inc (NASDAQ: CASI)
  • GenMark Diagnostics, Inc (NASDAQ: GNMK)
  • Lantheus Holdings Inc (NASDAQ: LNTH) (announced an amendment to the merger agreement with Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX), hiking the offer price)
  • MediciNova, Inc. (NASDAQ: MNOV)
  • OraSure Technologies, Inc. (NASDAQ: OSUR) (reacted to quarterly results)
  • Predictive Oncology Inc (NASDAQ: POAI)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)
  • STRATA Skin Sciences Inc (NASDAQ: SSKN)
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO)

See also: The Week Ahead In Biotech: Baudax Bio, Merck, Esperion Await FDA Decisions

Stocks In Focus Baudax Bio's Non-Opioid Pain Drug Approved By FDA

Baudax Bio Inc (NASDAQ: BXRX) said the FDA has approved its NDA for Anjeso, chemically meloxicam injection, which is indicated for the management of moderate-to-severe pain, alone or in combination with other non-NSAID analgesics.

The company said it expects to make the product available to physicians and patients in late April or early May 2020.

The stock jumped 27.52% to $10.20 in after-hours trading.

BioMarin Announces FDA Acceptance Of Regulatory Application For Hemophilia Gene Therapy

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) said the FDA has accepted for Priority Review its BLA for its investigational AAV5 gene therapy valoctoocogene roxaparvovec for adults with hemophilia A.

Taro Recalls 2 Lots of Seizure Drug

Taro Pharma said it is voluntarily recalling two lots of seizure drug Phenytoin oral suspension USP, 125 mg/5mL, both in 237 mL bottles, to the consumer level. The company attributed the recall to the product form these two lots not suspending when shaken, which could result in under or overdosing.

CASI Pharma Terminates Services of CFO

CASI Pharmaceuticals said in a Form 8-K filing it has agreed with CFO George Chi to terminate the latter's services as CFO, effective Friday. The company said it has determined to treat Chi's separation from the company as "without cause" as defined in the employment agreement.

Earnings

Agile Therapeutics Inc (NASDAQ: AGRX), which recently received approval for its Twirla contraceptive patch, reported a fourth-quarter loss of 10 cents per share, wider than the 7-cent loss expected by analysts. Cash and cash equivalents as of Dec. 31, 2019 stood at $34.5 million, including the proceeds of the Perceptive credit agreement received to date.

Agile said it will require additional capital to fund operating needs beyond 2020.

Separately, the company said it intends to offer shares of its common stock in an underwritten public offering. All the shares are being offered by the company.

The stock was down 15.08% at $3.04 in Friday's premarket session.

Aerie Pharmaceuticals Inc's (NASDAQ: AERI) fourth-quarter product revenue climbed from $14.46 million in 2018 to $24.66 million in 2019, ahead of the consensus estimate of $19.46 million. The net loss per share widened from $1.14 to $1.21.

The company said it expects 2020 net revenue to be in the range of $100 million to $110 million and net cash used in operating activities in the range of $110 million to $120 million. Analysts, on average, estimate revenues of $101.02 million.

The stock was up 14.38% at $22.75 at the time of publication in Friday's premarket session.

Anika Therapeutics Inc (NASDAQ: ANIK) reported a 10% year-over-year increase in total revenue to $29.8 million. The company reported adjusted non-GAAP net income of 43 cents per share. The results were ahead of expectations.

View more earnings on IBB

The stock was rallying by 9.4% to $45.95 in Friday's premarket session.

Puma Biotechnology Inc (NASDAQ: PBYI) reported fourth-quarter revenue of $62.9 million, largely comprised of Nerlynx sales of $58.7 million — a decline from net revenue of $71.1 million one year ago. The net loss per share narrowed from 80 cents to 29 cents, while analysts expected a wider loss of 48 cents per share.

The stock slipped 10.32% to $12.52 in after-hours trading.

Offerings

BioSig Technologies Inc (NASDAQ: BSGM) said it intends to offer shares of its common stock in a "best efforts" underwritten public offering.

The stock was slipping 9.11% to $4.09 in Friday's premarket session.  

Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) said it intends to offer shares of its common stock in an underwritten public offering. All the shares are being offered by EyePoint.

The stock was falling 23.08% to $1.50 in Friday's premarket session. 

Akari Therapeutics PLC (NASDAQ: AKTX) said it has entered into definitive agreements with certain accredited investors, including Chairman Dr. Ray Prudo, to raise gross proceeds of about $6 million through the private placement of shares.

In connection with the offering, the company said it will issue unregistered ADSs at $1.70 per ADS. The investors will also receive an unregistered warrant to purchase one-half ADS.

The stock was down 4.52% to $1.50 in the premarket session.

On The Radar PDUFA Dates

The FDA is expected to rule on Esperion Therapeutics Inc's (NASDAQ: ESPR) Bempedoic acid as a treatment option for elevated LDL cholesterol.

Related Link: Attention Biotech Investors: Mark Your Calendar For These February PDUFA Dates

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