The Daily Biotech Pulse: Glaukos Gets FDA Nod, Neurocrine Preannounces Soft Ingrezza Sales, 3 IPOs

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

Stocks In Focus

Hepion's Lead NASH Drug Candidate Gets The Non-Proprietary Name Rencofilstat

Hepion Pharmaceuticals, Inc. HEPA announced the United States Adopted Names Council has adopted the nonproprietary name "rencofilstat" for the company's lead drug candidate, CRV431. Rencofilstat is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease.

Glaukos' iPRIME Viscodelivery System Used In Ophthalmic Surgery Gets FDA Clearance

Glaukos Corporation GKOS announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the iPRIME™ Viscodelivery System, a sterile, single-use, minimally-invasive device for the delivery of viscoelastic fluid during ophthalmic surgery.

The stock was up 3.22% at $46.80 in premarket trading.

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ICU Medical Completes Smiths Medical Acquisition

ICU Medical, Inc. ICUI announced that it has completed its acquisition of Smiths Medical from Smiths Group plc SMGZY.

The Smiths Medical business includes syringe and ambulatory infusion devices, vascular access, and vital care products. When combined with ICU Medical's existing businesses, the combined companies create a leading infusion therapy company with estimated pro forma revenues of approximately $2.5 billion.

4D Molecular Commences Phase 1/2 Study Of Retinal Disorder Drug

4D Molecular Therapeutics, Inc. FDMT announced that the first patient has been dosed in the Phase 1/2 clinical trial of 4D-150 for neovascular age-related macular degeneration.

Neurocrine Biosciences Preannounces Soft Ingrezza Revenues

Neurocrine Biosciences, Inc. NBIX announced preliminary fourth-quarter href="https://www.benzinga.com/analyst-ratings/analyst-color/17/04/9293961/approval-for-neurocrines-ingrezza-was-no-surprise-but-la">Ingrezza net sales of $301 million, up 25% year-over-year. Analysts, on average, expect the company to report revenues of $320.5 million, with the estimated revenues also including collaboration revenues.

The stock was slipping 2.20% at $80.80 in premarket trading.

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

IPOs

Amylyx Pharmaceuticals, Inc. AMLX, a clinical-stage pharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis and other neurodegenerative diseases, priced its upsized initial public offering of 10 million shares at $19 per share.

All of the shares of common stock are being offered by Amylyx. Gross proceeds to Amylyx from this offering are expected to be $190 million. The shares will begin trading on the Nasdaq "AMLX."

CinCor pharma, Inc. CINC, a clinical-stage biopharma focused on developing its lead clinical candidate, CIN-107, for the treatment of hypertension and other cardio-renal diseases, priced its IPO of 12.1 million shares of common stock at $16 per share. The gross proceeds to CinCor from the offering are expected to be $193.6 million.

All of the shares are being offered by CinCor. The shares will begin trading on the Nasdaq under the symbol "CINC."

Vigil Neuroscience, Inc. VIGL, a clinical-stage biotech that harnesses the power of microglia for the treatment of neurodegenerative diseases, priced its IPO of 7 million shares of its common stock at 14 per share. All of the shares are being offered by Vigil Neuroscience. The gross proceeds of the offering are expected to be $98 million.

The shares are expected to begin trading on the Nasdaq under the ticker symbol "VIGL."