The Daily Biotech Pulse: Agile Receives Favorable Adcom Verdict, Merit Medical Tumbles On Earnings, 2 Biotechs To Debut

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs Oct. 30.)

• Allergan plc AGN
• Arrowhead Pharmaceuticals Inc ARWR
• AstraZeneca plc AZN
• Bioanalytical Systems, Inc. BASI
• Cabaletta Bio Inc CABA
• Deciphera Pharmaceuticals Inc DCPH
• ESSA Pharma Inc EPIX
• GENMAB A/S/S ADR GMAB
• GlaxoSmithKline plc GSK
• Novo Nordisk A/S NVO
• Reata Pharmaceuticals Inc RETA
• ResMed Inc. RMD
• Vertex Pharmaceuticals Incorporated VRTX
• ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks that hit 52-week lows Oct. 30.)

• Aridis Pharmaceuticals Inc ARDS
• Atara Biotherapeutics Inc ATRA
• BioCryst Pharmaceuticals, Inc. BCRX
• Champions Oncology Inc CSBR
• Cyclerion Therapeutics Inc CYCN (announced failed midstage trial and the elimination of 30 personnel)
• Diffusion Pharmaceuticals Inc DFFN
• Endologix, Inc. ELGX
• Iterum Therapeutics PLC ITRM
• MacroGenics Inc MGNX
• Paratek Pharmaceuticals Inc PRTK
• Trevi Therapeutics Inc TRVI

Stocks In Focus

FDA Panel Rules In Favor of Agile's Twirla

Agile Therapeutics Inc AGRX shares, which were pounded by about 76% over two sessions in the aftermath of the release of the FDA briefing document on its contraceptive patch Twirla, could be in focus yet again following the announcement of the Adcom meeting outcome.

The company said FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1 in favor of the approval of Twirla, deeming that the benefits in the prevention of pregnancy outweigh the risks to support approval.

The stock was rallying by 380.3% at $1.80 at the time of publication. 

See also: The Week Ahead In Biotech: Adcom Test For Agile; Pfizer, Merck Lead Earnings

Aradigm Withdraws European Filing For Lung Infection Drug

Aradigm Corporation ARDMQ said it has withdrawn its European regulatory filing for Linhaliq as a treatment option for non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

The company said the decision follows recent interactions with the EMA's Committee for Medicinal Products For Human Use that indicated the committee may formally adopt a negative opinion in its evaluation of the application,

Earnings

Merit Medical Systems, Inc. MMSI reported a sharp decline in its third-quarter non-GAAP earnings per share, from 47 cents to 28 cents, while analysts expected EPS of 45 cents. The company also lowered its 2019 net sales and EPS guidance, both of which are now indicated to come in below the consensus.

The stock was tumbling 36.28% to $18.55 in Thursday#39;s premarket session. 

Vertex Pharmaceuticals Incorporated VRTX reported a 21% increase in third-quarter product revenue to $950 million. Non-GAAP EPS climbed from $1.09 to $1.23. Analysts, on average, estimated EPS of $1.15. The company reiterated its recently updated product revenue guidance for 2019, which surrounded the consensus estimate,

Exelixis, Inc. EXEL reported third-quarter net revenue of $271.7 million, up from $225.4 million one year ago. Non-GAAP EPS slid from 44 cents to 34 cents.

The shares were slipping 3.39% to $16.79 in premarket trading Thursday.

On The Radar

PDUFA Dates

The FDA is set to rule on Adamis Pharmaceuticals Corp ADMP's NDA for higher dose naloxone spray, which is being evaluated as a treatment option for opioid overdose.

Earnings

• ABIOMED, Inc. ABMD (before the market open)
• Agios Pharmaceuticals Inc AGIO (before the market open)
• Akorn, Inc. AKRX (before the market open)
• Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
• Bristol-Myers Squibb Co BMY(before the market open)
• Intellia Therapeutics Inc NTLA (before the market open)
• Novocure Ltd NVCR (before the market open)
• Repligen Corporation RGEN (before the market open)
• Syneos Health Inc SYNH (before the market open)
• Lantheus Holdings Inc LNTH (before the market open)
• Celgene Corporation CELG
• Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO (after the close)

IPO

Oyster Point Pharma, a biotech developing a nasal spray formulation to treat dry eye disease, priced its IPO of 5 million shares at $16 against an estimated price range of $16-$18. The shares will be listed on the Nasdaq under the ticker symbol "OYST."

Rapt Therapeutics, a clinical-stage biopharma company focusing on cancer and inflammatory diseases, priced its 3-million-share IPO at $12, at the low end of the estimated price range of $12 and $14. The shares will begin trading on the Nasdaq under the ticker symbol "RAPT."

Related Link: Gilead Falls On Uninspiring Q3 Print: 3 Analyst Takes