Next week in biotech (April 24-April 30): Bristol-Myers Squibb, Supernus, Hutchmed, Axsome, Coherus FDA decisions, big pharma earnings, IPOs and more – Tips & Results

Biotech stocks extended their losses in the week ended April 22nd. The sector was led by the broader market reacting to a lackluster start to the first quarter earnings season and ongoing fears of interest rate hikes.

On the M&A front Regeneron Pharmaceuticals, Inc. REG announced a purchase agreement Checkmate Pharmaceuticals, Inc. CMPI for $250 million.

Johnson & Johnson, Inc. JNJ started the pharma reporting season with mixed results in the first quarter. The company withdrew its COVID-19 vaccine forecast for the year, citing excess global supply and demand uncertainty.

Here are the key catalysts for the unfolding week:

conferences

2022 American Society of Cataract and Refractive Surgery, or ASCRS, Annual Meeting: June 23-26 April in Washington, D.C

2022 Tandem Meetings – Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy, or ASTCT, and the Center for International Blood and Marrow Transplant Research, or CIBMTR: June 23-26 April in Salt Lake City, Utah

32nd European Congress of Clinical Microbiology and Infectious Diseases or ECCMID: April 23-26, will be held virtually and in Lisbon, Portugal

American Academy of Neurology, or AAN, Annual Meeting: Oct. 24-26 April in Seattle, Washington

The 2022 FDA/DIA Oligonucleotide-based Therapeutics Conference or Oligo22: Aug. April in Rockville, Maryland

2022 Combined Otolaryngology Spring Meetings, or COSM: April 27 – May 1, in Dallas, Texas.

PDUFA data

The Food and Drug Administration is scheduled to announce its verdict Bristol-Myers Squibb Company BMY new drug application to treat heart failure mavacamten. The decision will be made on Thursday, April 28.

Supernus Pharmaceuticals, Inc SUPN Application of a complementary new drug to expand Qelbree’s label to adult patients with Attention Deficit Hyperactivity Disorder has a PDUFA target date of Friday April 29th.

The FDA should also decide on this HUTCHMED (China) Limited HCM NDA for surufatinib as a treatment option for pancreatic and extrapancreatic neuroendocrine tumors. The decision is expected by Saturday, April 30th.

Axsome Therapeutics, Inc. AXSM has a PDUFA target date of Friday for his NDA for meloxicam-rizatriptan in acute migraine.

The drug regulator is also expected to announce its decision Coherus BioSciences, Inc CHRS Biologics Application for Toripalimab in Nasopharyngeal Cancer. The PDUFA target date is Saturday.

Related Link: Attention biotech investors: mark PDUFA dates in April

Clinical ads/presentations

Nkarta, Inc. NKTX is scheduled to host a conference call Monday at 8:00 a.m. ET to review clinical data from Phase 1 clinical trials evaluating two lead clinical programs, NKX101 and NKX019. The former is being studied for acute myeloid leukemia/myelodysplastic syndromes and the latter for B-cell malignancies.

Arrowhead Pharmaceuticals, Inc. ARWR will present phase 1b data for ARO-HIF2 in clear cell renal cell carcinoma at the Oligo22 conference.

Ocuphire Pharma, Inc. OKUP will present Phase 2 data for Nyxol in presbyopia at the ASCRS meeting. (Monday)

Cidara Therapeutics, Inc. CDTX to present Phase 2/3 data on rezafungin in candidaemia at ECCMID. (Monday)

Magenta Therapeutics, Inc. MGTA will present phase 2 data for MGTA-145 in combination with plerixafor in patients with multiple myeloma at the TCT conference. (Tuesday)

Merck & Company, Inc. MRK will present phase 3 data for oral COVID pill Lagevrio, formerly molnupiravir, in COVID-19 patients at ECCMID conference.

Lyra Therapeutics, Inc. LYRA will present phase 2 data for LYR-210 in chronic rhinosinusitis at the COSM conference. (Thursday)

Tarsus Pharmaceuticals, Inc. TARS expects to release Phase 3 topline data for TP-03 in Demodex blepharitis in April.

merits

The income list provided is not complete. Click here to access Benzinga’s earnings calendar and view the full schedule

Tuesday

Neurometrix, Inc. NURO (before market opening)

Wednesday

Boston Scientific Corporation BSX (before market opening)

Alkermes plc ALKS (before market opening)

Integra LifeSciences Holdings Corporation IART (before market opening)

amgen inc AMGN (after the end)

BioMarin Pharmaceutical Inc. BMRN (after the end)

Thursday

Merck (before market opening)

Eli Lilly & Co LLY (before market opening)

Alnylam, Inc. ALNY (before market opening)

Friday

AbbVie, Inc. ABBV (before market opening)
Birstol-Myers Squibb (before market open)

IPOs

IPO prices

Based in San Diego, California Belite Bio, Inc. BLTE, a clinical-stage biopharmaceutical company focused on therapies for retinal diseases, has filed an application to offer 6 million shares in an initial public offering. This Cayman Islands-exempted holding company expects an offer price of between $5.50 and $6.50 per ADS. The company has applied to list its ADSs on the Nasdaq.

Medical Device Company Tenon Medical, Inc. TNON plans to offer 4 million shares in an IPO with an estimated price range of $4.50 to $5.50 per share. Based in Los Gatos, California, the company intends to list its shares on the Nasdaq under the ticker symbol TNON.

Related link: Biogen fails to convince European regulator of Alzheimer’s drug’s benefits

Leave a Comment