The Week Ahead In Biotech (Oct. 24-30): Eyenovia, ANI Pharma, Clearside Medical FDA Decisions, Merck, Bristol-Myers Squibb Earnings, IPOs And More

Biotech stocks posted gains for the second week running, supported by multiple catalysts that included a good start to the big pharma reporting season and broader market strength.

Johnson & Johnson JNJ kick-started earnings for the sector with strong quarterly results, buoyed by COVID vaccine revenues. The stock also benefited from the Food and Drug Administration's emergency use authorization for its COVID booster shot. The drug regulator authorized Moderna, Inc. MRNA's booster dose, as well.

In another positive development, the FDA gave its green light for the use of mix-and-match vaccine regimen, i.e. allowing the use of either Moderna, Pfizer, Inc. PFE-BioNTech SE BNTX or J&J booster shots following the administration of another approved vaccine as the primary series.

Sanofi SNY and Regeneron Pharmaceuticals, Inc. REGN received a regulatory nod for the expanded use of their Dupixent as an add-on treatment for asthma in children.

Ventyx Biosciences, Inc. VTYX, Minerva Surgical, Inc. UTRS and Context Therapeutics Inc. CNTX were among the healthcare initial public offerings that were priced during the week.

Here are the key catalysts for the upcoming week:

Conferences

American College of Gastroenterology, or ACG, 2021 Annual Scientific Meeting (hybrid meeting): Oct. 22-27 (in Mandalay Bay, Las Vegas)

American Society of Radiation Oncology, or ASTRO, 2021 Annual Meeting: Oct. 24-27 (in Chicago)

PDUFA Dates

The FDA is set to rule on Eyenovia, Inc. EYEN's new drug application for MydCombi, a pupil dilation agent for eye examination. The PDUFA date has been fixed for Thursday, Oct. 28.

ANI Pharmaceuticals, Inc. ANIP has a tryst with the FDA this week, as the regulator is scheduled to rule on the company's supplemental NDA for purified Cortrophin gel, a purified adrenocorticotropic hormone, for multiple indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome. The decision is expected by the PDUFA date of Friday, Oct. 29.

The FDA is also expected to announce by Saturday, Oct. 30 its verdict on Clearside Biomedical, Inc. LSD & Bausch Health Companies Inc. BHC's NDA for Xipere (triamcinolone acetonide) as a treatment option for macular edema associated with uveitis.

Related Link: Merck's Oral COVID-19 Treatment Could Be Game-Changer: BofA Analyst

Clinical Readouts/Presentations

Checkmate Pharmaceuticals, Inc. CMPI will present in a live webcast hosted by Jefferies, data on innate immune modulators and vidutolimod (CMP-001). The webcast is scheduled for Tuesday, Oct. 26, between 11am and 12pm.

9 Meters Biopharma, Inc. NMTR is scheduled to present at the ACR Meeting, Phase 2 data vurolenatide, its therapeutic candidate in short bowel syndrome. (Tuesday, Oct. 26)

ASTRO Meeting Presentations

Nanobiotix S.A. NBTX: Updated data from Study 1100, a phase 1 basket study evaluating NBTXR3 activated by radiotherapy in combination with Bristol-Myers Squibb BMY's Opdivo or Merck & Co., Inc. MRK's Keytruda in locoregional recurrent or recurrent metastatic head & neck squamous cell carcinoma (Tuesday, Oct. 25, at 5 pm); Phase 1 study of NBTXR3, in combination with Opdivo and Keytruda in advanced cancer patients (Tuesday, Oct. 25, 5 pm), data from the Phase 1 Study of NBTXR3 in locally advanced HNSCC patients (Oct. 26, at 2:15 pm)

Adaptimmune Therapeutics plc ADAP: results from the Phase 1 radiation sub-study of ADP-A2M4 in solid tumors

Earnings

Tuesday

Eli Lilly and Company LLY (before the market open)

Wednesday

Thermo Fisher Scientific Inc. TMO (before the market open)
Genocea Biosciences, Inc. GNCA (before the market open)
Boston Scientific Corporation BSX (before the market open)
Alkermes plc ALKS (before the market open)
Bristol-Myers Squibb (before the market open)
BioMarin Pharmaceutical Inc. BMRN (after the close)
Edwards Lifesciences Corporation EW (after the close)

Thursday

Merck (before the market open)
Evelo Biosciences, Inc. EVLO (before the market open)
Baxter International Inc. BAX (before the market open)
NovoCure Limited NVCR (before the market open)
Repligen Corporation RGEN (before the market open)
Blueprint Medicines Corporation BPMC (before the market open)
Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
Laboratory Corporation of America Holdings LH (before the market open)
Alimera Sciences, Inc. ALIM (before the market open)
Bio-Rad Laboratories, Inc. BIO (after the close)
PTC Therapeutics, Inc. PTCT (after the close)
Merit Medical Systems, Inc. MMSI (after the close)
LeMaitre Vascular, Inc. LMAT (after the close)
Travere Therapeutics, Inc. TVTX (after the close)
Taro Pharmaceutical Industries Ltd. TARO (after the close)
ResMed Inc. RMD (after the close)
CareDx, Inc CDNA (after the close)

Friday

AbbVie Inc. ABBV (before the market open)
ImmunoGen, Inc. IMGN (before the market open)
IRadimed Corporation IRMD (before the market open)

IPOs

IPO Pricing

Princeton, New Jersey-based LianBio LIAN has filed a preliminary prospectus with the SEC to offer 20.3125 million ADSs (American Depository Shares), representing 20.3125 million ordinary shares at an estimated price range of $15 and $17. The biopharma dedicated to developing medicines for patients with unmet medical needs, with an initial focus on in-licensing assets for Greater China and other Asian markets, expects to list its shares on the Nasdaq under the ticker symbol "LIAN."
Aesthetic medical device company Candela Medical, Inc. is proposing to offer 14.71 million shares in an IPO. The Marlborough, Massachusetts-based company expects to price the offering between $16 and $18. The shares will likely begin trading on the Nasdaq under the ticker symbol "CDLA."
IPO Quiet Period Expiry

Exscientia plc EXAI

Related Link: Novavax Shares Plunge To Lowest Levels Since Mid-May As COVID-19 Vaccine Woes Continue