Why TFF Pharmaceuticals Shares Are Sinking

 

• TFF Pharmaceuticals Inc 
  TFFP-35.2%+ Free Alerts
   shares are tumbling after program updates for Voriconazole Inhaled Powder (TFF VORI) and Tacrolimus Inhaled Powder (TFF TAC) clinical programs.
• The company expects to deliver preliminary patient data from the Phase 2 study of TFF VORI in the first quarter of 2023 and TFF TAC in the second quarter of 2023. 
• The timing of data release has been updated due to several challenges related to staffing shortages, shipping, and global supply chain delays.
• "Clinical trial operations and logistics for much of the pharmaceutical industry, including TFF, continue to be impacted by ongoing staffing shortages and global supply chain constraints, which have subsequently led to challenges in predicting enrollment and data readouts," said Glenn Mattes, CEO 
• Concurrently, the company announced that a second patient had been treated with its proprietary Voriconazole Inhalation Powder (TFF VORI) through a compassionate use program. 
• TFF VORI is a next-generation, direct-to-lung, inhaled dry powder formulation of voriconazole for Invasive Pulmonary Aspergillosis.
• The patient had a history of skin cancers and multiple fungal infections.
• Following the initiation of TFF VORI therapy, the patient's lung function stabilized, and no dose modification of tacrolimus was required.

https://www.benzinga.com/general/biotech/22/11/29525521/why-tff-pharmaceuticals-shares-are-sinking-today

Blueprint Gets Price Target Cut Amid Lower Than Expected Ayvakit Uptake

 

• HC Wainwright lowered the price target on Blueprint Medicines Corp 
  BPMC-4.44%+ Free Alerts
  , keeping the Buy rating.
• Blueprint expects to submit a supplemental application for Ayvakit in non-advanced systemic mastocytosis (non-ADvSM) in 4Q22 (expected launch in mid-2023), with the longer-term value being driven by an expanding suite of precision medicines aimed at NSCLC and beyond. 
• The analyst has long believed that Ayvakit will gain approval in non-ADvSM but concurrently believe that the elucidation and treatment of these patients will be an uphill battle for Blueprint. 
• The company has outlined the initial launch strategy to concentrate on patients with moderate to severe disease (~7,500 pts) to promote faster patient uptake, but the strategy omits another 22K undiagnosed or misdiagnosed patients, leaving room for a potential blockbuster opportunity, the analyst writes.
• Lower-than-expected initial penetration in SM AHN compared to other subtypes, coupled with COVID-19 impacts and FX headwinds, further adds to the overall slowing uptake seen for Ayvakit. 
• Blueprint lowered Ayvakit’s FY22 sales guidance to $108-111 million, down from $115-130 million, leaving investors speculating how Blueprint’s experience in advanced SM will translate to non-ADvSM.

https://www.benzinga.com/general/biotech/22/11/29529197/blueprint-medicines-stock-gets-price-target-cut-amid-lower-than-expected-ayvakit-uptake

AbCellera’s First Program with Regeneron in Multi-Target Collaboration Advances in Preclinical Development

  AbCellera (Nasdaq: ABCL) announced today that Regeneron has elected to exercise its right to advance a therapeutic antibody candidate, discovered in partnership with AbCellera as part of a multi-target collaboration between the companies, into further preclinical development. The partnership, which commenced in March 2020 and allows for four discovery programs selected by Regeneron, leverages AbCellera’s antibody discovery engine and Regeneron’s VelocImmune® mice to identify novel therapeutic antibodies. This is the first potential candidate selected by Regeneron to move into further evaluation, and it targets an undisclosed G-protein coupled receptor (GPCR).

“By solving technology-intensive challenges that have hindered antibody discovery against difficult and sought-after drug targets, we’re able to open up opportunities for leading companies in our industry,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “We are pleased our partnership with Regeneron has resulted in this first early-stage antibody candidate and look forward to continue empowering drug discovery for Regeneron’s clinical pipeline.”

Under the terms of the agreement, Regeneron has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera receives research payments and is eligible to receive downstream clinical and commercial milestone payments and royalties on net sales of products. AbCellera received a milestone payment for this antibody candidate and the amount of the payment was not disclosed.

https://www.biospace.com/article/releases/abcellera-s-first-program-with-regeneron-in-multi-target-collaboration-advances-in-preclinical-development/