Pliant Therapeutics Gets Fast Track Pulmonary Fibrosis Treatment

 Pliant Therapeutics Inc. said that PLN-74809, its oral, dual-selective integrin inhibitor, has received fast track designation from the U.S. Food and Drug Administration for the potential treatment of idiopathic pulmonary fibrosis.

The company said PLN-74809 is currently being tested as part of a Phase 2a clinical trial.

Pliant said it anticipates topline data from this randomized, double-blind, placebo-controlled trial in patients with idiopathic pulmonary fibrosis in mid-2022.

FDA's fast track designation is intended to speed up the development and review of new drugs to treat serious or life-threatening conditions.

https://www.marketscreener.com/quote/stock/PLIANT-THERAPEUTICS-INC-107768551/news/Pliant-Therapeutics-Gets-Fast-Track-Designation-for-PLN-74809-for-Treatment-of-Idiopathic-Pulmonary-40256961/

Bayer wins U.S. priority review of drug against metastatic prostate cancer

 Bayer's Nubeqa drug won priority review status from the U.S. Food and Drug Administration, as the German drugmaker seeks to widen the use of the prostate cancer drug from an early disease stage to metastatic cases.

The priority status was granted as the U.S. regulatory body accepted Bayer's supplemental New Drug Application (sNDA) for the use of Nubeqa, jointly developed with Finnish drugmaker Orion, against metastatic hormone-sensitive prostate cancer, Bayer said in a statement on Tuesday.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-wins-U-S-priority-review-of-drug-against-metastatic-prostate-cancer-40255144/

Belite Bio Shares Jump 47% After Fast-Track for Treatment for Stargardt Disease

 Belite Bio Inc. shares rose 47% to $13.05 after the company said its LBS-008, an orally administered tablet, has been granted fast-track designation by the Food and Drug Administration for the treatment of Stargardt disease, or STGD1, a retinal disease with the potential to severely affect vision.

The company said the decision was based upon the FDA's review of nonclinical data and preliminary clinical data from studies of LBS-008.

The stock hit its 52-week low of $8.80 on Monday, when it closed down 16%.

Belite said it is conducting a Phase 3 clinical trial to bring to market a treatment that will halt or slow the progression of STGD1. It is evaluating a plan to launch a Phase 2/3 trial in atrophic age-related macular degeneration in 2022, it said.

The company said it expects the next near-term data readout in its STGD1 Phase 2 trial in the last quarter of this year when all subjects have completed 12 months of treatment.

https://www.marketscreener.com/quote/stock/BELITE-BIO-INC-136829476/news/Belite-Bio-Shares-Jump-47-After-Fast-Track-Designation-for-LBS-008-Treatment-for-Stargardt-Disease-40258997/

Former AstraZeneca oncology head to help All Blue in Zymeworks takeover bid

 

Investment firm All Blue Capital would be advised by Alan Barge, former oncology head at British drugmaker AstraZeneca Plc, in its bid to acquire drug developer Zymeworks Inc, according to a press statement seen by Reuters.

All Blue late last month approached Vancouver, Canada-based Zymeworks, which is developing antibody therapies for cancer, with a $773 million acquisition offer.

Barge recently joined All Blue as oncology drug development advisor and would assist the firm in "reversing the value-destructive measures" that Zymeworks implemented over the past twelve months, according to the statement.

"I have worked closely with the team in developing a business plan for Zymeworks that can create superior value," Barge said in the statement.

Upon successful completion of the deal, Barge would serve on Zymeworks' board, according to the statement.

All Blue is a technology-focused investment firm, whose investments include Airbnb, SpaceX and Lyft. It currently holds a small stake in Zymeworks.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Former-AstraZeneca-oncology-head-to-help-All-Blue-in-Zymeworks-takeover-bid-40259462/

Why Kymera Therapeutics Stock Is Getting Hammered

 Shares of Kymera Therapeutics (NASDAQ: KYMR), a clinical-stage biopharmaceutical company, are tumbling in response to its latest quarterly update.

Kymera said it is updating a clinical trial testing the company's lead candidate, which will cause the study to last longer than expected, and disappointed investors pushed the stock down 24.6% as of 11:24 a.m. ET on Tuesday.

Kymera Therapeutics reported first-quarter 2022 results this morning. As a pre-commercial business without any products to sell, all eyes were on the company's lead candidate, an IRAK4 degrader called KT-474. Investors began the morning with a bad taste in their mouth for KT-474 because Pfizer recently discontinued the development of a candidate that works along the same lines after advancing it into phase 2 testing.

Kymera's IRAK4 candidate is still in a phase 1 trial that so far has only tested healthy volunteers, not people with autoimmune disorders like eczema that KT-474 is designed to treat. Kymera's stock is tanking today because the company told investors it would extend its phase 1 trial to account for a longer dosing period. The company also intends to incorporate new clinical endpoints for the patients it intends to enroll in the next part of its ongoing phase 1 study.

When they woke up this morning, Kymera Therapeutics investors were expecting to hear that KT-474 would progress into a phase 2 trial soon. Instead, the company told investors it would send patient data from its elongated phase 1 trial to its collaboration partner Sanofi in the second half of 2022 before starting a phase 2 trial. Now, investors are worried Sanofi could walk away from KT-474 the same way Pfizer just walked away from its own IRAK4 inhibitor.

When presenting first-quarter results, Kymera was awfully quick to tell investors that it had initiated clinical trials for two new oncology candidates. This pivot away from KT-474 could be a simple attempt to diversify its operation, but it can also be taken as a sign that the company lacks confidence in its lead candidate.

https://www.nasdaq.com/articles/why-kymera-therapeutics-stock-is-getting-hammered-today

FDA Identifies Review Issues For Spero's Tebipenem Application, Shares Plunge

 

• Spero Therapeutics Inc (NASDAQ: SPRO) will defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting (LCM) with the FDA.

• The discussion suggested that the data package may be insufficient to support approval during this review cycle.

• In evaluating the efficacy of tebipenem HBr in Phase 3 (ADAPT-PO) cUTI study, the FDA conducted a separate analysis of the microbiological intent-to-treat (micro-ITT) population.

• The effect of this new analysis was to reduce the number of evaluable patients in the primary analysis population compared with those resulting from the trial's pre-specified micro-ITT population as outlined in the statistical analysis plan.

• Hence, the FDA considers that the pre-specified non-inferiority margin of -12.5% was not met.

• With this development, Spero will reduce its workforce by approximately 75% to 35 from 146 full-time employees.

• The company will incur approximately $8.0 million in severance costs.

• Spero would prioritize advancing SPR720 and SPR206 to Phase 2 milestones, including key deliverables through 2024, while engaging with the FDA on the appropriate path forward for tebipenem HBr.

• Spero ended 2021 with an estimated $146.4 million in cash. Based on the anticipated cost savings, the company anticipates a cash runway into late 2023.

https://finance.yahoo.com/news/fda-identifies-review-issues-speros-135955381.html

GOP condemns leak of Supreme Court draft abortion ruling

 Republicans spoke out Monday night in response to the leak of a Supreme Court draft ruling that would overturn Roe v. Wade.

Politico published what it said was a draft majority decision, authored by conservative Justice Samuel Alito, that would end federal abortion rights, returning to the state level the legality of the procedure.

While Democrats denounced the substance of the draft ruling, GOP leaders condemned the leak itself, with some saying it was evidence of hostility toward conservative views.

“The left continues its assault on the Supreme Court with an unprecedented breach of confidentiality, clearly meant to intimidate,” Sen. Josh Hawley (R-Mo.) tweeted. “The Justices mustn’t give in to this attempt to corrupt the process. Stay strong.”

It was unclear who provided the document to Politico, which pointed out that an official ruling isn’t expected for weeks.

Sen. Rick Scott (R-Fla.) concurred with Hawley that “​​this breach shows that radical Democrats are working even harder to intimidate & undermine the Court.”

“It was always their plan. The justices cannot be swayed by this attack,” Scott added.

Sen. Marco Rubio (R-Fla.) said, “The next time you hear the far left preaching about how they are fighting to preserve our Republic’s institutions & norms remember how they leaked a Supreme Court opinion in an attempt to intimidate the justices on abortion.”

Sen. James Lankford (R-Okla.) pointed out, however, that there is “no way to verify if it is accurate and, if it is, who leaked it or why.”

Sen. Tom Cotton (R-Ark.) urged a probe into the source of the leak.

“The Supreme Court & the DOJ must get to the bottom of this leak immediately using every investigative tool necessary,” Cotton wrote.

“The Court should not abide this coordinated assault by the Left. Issue the decision now,” urged Hawley.

https://thehill.com/news/senate/3474809-republicans-condemn-leak-of-supreme-court-draft-abortion-ruling/