The Daily Biotech Pulse: FDA Nod For Lilly-Incyte's Patchy Hair Loss Treatment, First Regulatory Submission For EQRx, Soleno's Promising Data From Prader-Willi Candidate

Zinger Key Points
  • Pfizer, MorphoSys AG, and Incyte have announced a clinical trial collaboration and supply agreement.
  • The FDA approved Eli Lilly-Incyte's once-daily pill, as a first-in-disease systemic treatment for severe alopecia areata.

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

Stocks In Focus

Soleno's DCCR Data Shows Metabolic, Body Composition Improvements In Prader-Willi Patients

Soleno Therapeutics Inc SLNO presented new data from its ongoing late-stage DCCR development program for Prader-Willi syndrome (PWS) at ENDO 2022.

A chronic feeling of insatiable hunger characterizes PWS.

Patients (n=82) experienced improvements in body composition, as evidenced by statistically significant changes in lean body mass and the ratio of lean body mass to fat mass.

Shares are up 35.4% at 23 cents during the premarket session.

Pfizer, MorphoSys, Incyte Ink Pact For Immunotherapy Combo Trial In Lymphoma Setting

Pfizer Inc PFEMorphoSys AG MOR, and Incyte Corporation INCY have announced a clinical trial collaboration and supply agreement.

The agreement will investigate the immunotherapeutic combination of TTI-622 and Monjuvi plus lenalidomide for relapsed or refractory diffuse large B-cell lymphoma not eligible for autologous stem cell transplantation.

Pfizer will initiate a Phase 1b/2 study. MorphoSys and Incyte will provide Monjuvi for the study, which Pfizer will sponsor and fund.

FDA Approves Eli Lilly/Incyte's Baricitinib For Patchy Baldness

The FDA approved Eli Lilly And Co LLYIncyte Corporation's INCY Olumiant (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata.

Olumiant is not recommended for use with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Also Read: 5 Biotech Stocks To Watch During The Week Of June 13

FDA Approves Alnylam's Vutrisiran For Amyloidosis-Associated Polyneuropathy

The FDA has approved Alnylam Pharmaceuticals Inc's ALNY Amvuttra (vutrisiran) for polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 

The FDA approval is based on positive 9-month results from the HELIOS-A Phase 3 study, where AMVUTTRA significantly improved the signs and symptoms of polyneuropathy, with more than 50% of patients experiencing halting or reversal of their disease manifestations.

Shares closed 6.50% higher at $136.00 during the after-hours session.

Freeline Starts Dosing In Second Cohort Of Hemophilia Trial

Freeline Therapeutics Holdings plc FRLN has begun dosing the second cohort in its Phase 1/2 B-LIEVE trial of FLT180a in hemophilia B. 

Based on the strength of the data from cohort one and consistent with the advice of an Independent Data Monitoring Committee, patients in cohort two will receive the same low dose (7.7e11 vg/kg) of FLT180a. The dosing of the first cohort was completed in April, and initial data from that cohort will be presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress next month.

EQRx Makes First Submission To A Regulatory Agency

The U.K.'s regulatory agency has accepted EQRx Inc's EQRX marketing application for aumolertinib for locally advanced or metastatic non-small cell lung cancer (NSCLC).

The application covers patients with activating EGFR mutations and adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

The marketing authorization application is EQRx's first submission to a regulatory agency.

Click here to access Benzinga's FDA Calendar.

FDA Grants Pre-NDA Meeting For Stealth Bio's Elamipretide as a Potential Treatment for Barth Syndrome

Stealth BioTherapeutics Corp MITO plans to meet with the FDA's Division of Cardiology and Nephrology to discuss new clinical data that may inform a potential marketing application submission for Barth Syndrome.

The FDA has granted the meeting request, which is expected to occur in Q3. 

Insider Trading

NGM Biopharmaceuticals Inc NGM: TCG IV GP LLC, with over 10% of ownership, reported a purchase of 984,161 shares at an average price of $13.50/share.


Day One Biopharmaceuticals Inc DAWN has commenced an underwritten public offering of $125 million shares.

Shares are down 11.8% at $13.19 during the premarket session.

On The Radar

FDA AdComm Meeting

Discuss amending the emergency use authorization of the Moderna Inc's MRNA COVID-19 mRNA vaccine to include administering the primary series to children and adolescents six years of age through 17. 

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