Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Arcutis Psoriasis Treatment Scores FDA Approval
The FDA approved Arcutis Biotherapeutics Inc's (NASDAQ:ARQT) Zoryve (roflumilast) cream 0.3% for plaque psoriasis, including intertriginous areas, in patients 12 years of age or older.
It is the first and only topical phosphodiesterase-4 inhibitor approved for plaque psoriasis.
The commercial product is expected to be available by mid-August.
Arcutis expects to draw an additional $125 million from the company's debt facility with SLR Capital Partners.
Shares are up 3.05% at $25 during the premarket session.
FDA Removes Clinical Hold On Celyad's Colorectal Cancer Trial
The FDA has lifted the clinical hold on Celyad Oncology SA's (NASDAQ:CYAD) CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the company made changes to the eligibility criteria for the trial.
In February, the company voluntarily paused the CYAD-101-002 trial to investigate reports of two fatalities in the study.
The FDA subsequently put the trial on clinical hold in March.
Shares are up 40.9% at $2.41 during the premarket session.
HUTCHMED Starts Midstage Tazemetostat Study For Lymphoma Setting
HUTCHMED (China) Limited (NASDAQ:HCM) initiated a bridging Phase 2 study of tazemetostat in China for relapsed/refractory follicular lymphoma (R/R FL).
The first patient received their first dose on July 29.
The primary objective is to evaluate the efficacy of tazemetostat in R/R FL patients with mutations in EZH21 (Cohort 1).
The secondary objectives are to evaluate the efficacy of tazemetostat for R/R FL with EZH2 wild-type.
Related: Biotech Investors: August's Key PDUFA Catalysts You Must Know.
FDA Signs Off On Eledon Pharma's Tegoprubart For Kidnety Transplant Rejection
The FDA has cleared Eledon Pharmaceuticals Inc's (NASDAQ:ELDN) Investigational New Drug (IND) application to evaluate tegoprubart for preventing organ rejection in patients receiving a kidney transplant.
The IND-opening phase 2 study will enroll approximately 120 participants undergoing a kidney transplant.
Kazia Shares Fall After Update From Pivotal Brain Tumor Trial
Kazia Therapeutics Limited (NASDAQ:KZIA) said GBM AGILE, a pivotal study for paxalisib in newly diagnosed glioblastoma, did not meet pre-defined criteria for continuing to a second stage.
Patients enrolled in the first stage of the paxalisib arm will continue on treatment as per protocol, and in follow-up, until completion of the final analysis, which Kazia anticipates receiving in the second half of 2023.
The company will not open the study's paxalisib arm in Germany or China.
Shares are down 38.3% at $2.24 during the premarket session.
FDA Places Clinical Hold On Beam Therapeutics' IND Application For Blood Cancer Study
The FDA has placed a clinical hold on Beam Therapeutics Inc's (NASDAQ:BEAM) BEAM-201 Investigational New Drug (IND) application for relapsed/refractory T-cell acute lymphoblastic leukemia/T cell lymphoblastic lymphoma.
The BEAM-201 IND was submitted at the end of June. The FDA indicated it would provide Beam with an official clinical hold letter within 30 days. Beam plans to provide additional updates pending discussion with the FDA.
Otonomy Shares Sink After Stopping Midstage Tinnitus Study
Otonomy Inc (NASDAQ:OTIC) has announced that the OTO-313 Phase 2 trial in tinnitus demonstrated no clinically meaningful benefit versus placebo for primary and secondary endpoints across all time points.
The 153-subject study did show a higher response rate than placebo in a prospectively defined patient subgroup with tinnitus duration of fewer than six months (population studied in Phase 1/2 trial).
The overall results do not support further development of OTO-313.
Shares are slipping 60.8% at 56 cents during the premarket session.
AstraZeneca Cuts Innate-Partnered Phase 3 Trial In Head, Neck Cancer
Innate Pharma SA's (NASDAQ:IPHA) futility interim analysis of the INTERLINK-1 Phase 3 study sponsored by AstraZeneca Plc (NASDAQ:AZN) did not meet a pre-defined threshold for efficacy.
Based on this result and the recommendation of an Independent Data Monitoring Committee, AstraZeneca has informed Innate that the study will be discontinued.
There were no new safety findings. AstraZeneca plans to share the data in due course.
IPHA shares are down 16.3% at $2.68 during the premarket session.
ALX Oncology's Evorpacept Fast Tracked In US For Head, Neck Cancer
The FDA has granted Fast Track designation to ALX Oncology Holdings Inc's (NASDAQ:ALXO) evorpacept in combination with Merck & Co Inc's (NYSE:MRK) Keytruda for the first-line treatment of PD-L1 positive advanced head and neck squamous cell carcinoma.
The FDA's decision is informed by the results of ALX Oncology's phase 1 study that showed preliminary antitumor activity and a favorable safety profile.
Shares are up 5.48% at $10.26 during the premarket session.
Offerings
TherapeuticsMD Inc (NASDAQ:TXMD) has received a $15-million private investment in the company's common stock and a new series of preferred stock from Rubric Capital Management LP.
On The Radar
Earnings
Cerevel Therapeutics Holdings Inc (NASDAQ:CERE): Before the market open.
