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Thursday, October 22, 2020

aTyr Pharma Inc (NASDAQ:LIFE) Jumps Higher on Fast Track Decision

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aTyr Pharma Inc (NASDAQ:LIFE) is a micro-cap name in the biotherapeutics space that has started to engage some focus among traders and investors as prices get a little traction in bounce mode. From what we can see, the recent spike in interest appears to be a product of the company’s recent announcement that its product candidate Resolaris was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), making it the first known therapeutic candidate for the treatment of LGMD2B to receive the designation.

In addition, the FDA removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials. We’ve witnessed 40% piled on for shareholders of the name during the trailing month, with 25% of that coming in the past few days. What’s more, the listing has witnessed a pop in interest, as transaction volume levels have recently pushed approaching 320% beyond what we have been seeing over the larger time frame.

aTyr Pharma Inc (NASDAQ:LIFE) trumpets itself as a biotherapeutics company, engages in the discovery and clinical development of Physiocrine-based therapeutics for patients suffering from severe and rare diseases.

LIFE develops Resolaris, which is in Phase Ib/II clinical trials for treating adult patients with facioscapulohumeral muscular dystrophy (FSHD), a rare genetic myopathy with an immune component; patients with early onset FSHD; and adult patients with limb-girdle muscular dystrophy 2B or FSHD. In addition, the company is developing iMod.Fc, a preclinical immuno-modulatory domain program.

The company was founded in 2005 and is headquartered in San Diego, California.

According to company materials, “aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients suffering from severe, rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators. The Company’s lead candidate, Resolaris™, is a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. aTyr has built an intellectual property estate, to protect its pipeline, comprising over 80 issued or allowed patents and over 230 pending patent applications that are owned or exclusively licensed by aTyr, including over 300 potential Physiocrine-based protein compositions. aTyr’s key programs are currently focused on severe, rare diseases characterized by immune dysregulation for which there are currently limited or no treatment options.”

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As noted above, the company just got word of the FDA’s decision to grant Resolaris Fast Track Status. That obviously has management excited and optimistic about the future of the company’s R&D efforts.

“This Fast Track designation, which is granted to drug candidates addressing serious conditions and that demonstrate the potential to address unmet medical needs, represents another step forward for our first product candidate based on the Physiocrine pathway,” said John Mendlein, PhD, CEO of aTyr Pharma. “Combined with our Phase1b/2 data in LGMD2B, adult facioscapulohumeral muscular dystrophy (FSHD) and early onset FSHD patients, we believe we are building a clinical and regulatory foundation for future development of Resolaris to treat patients across multiple rare genetic myopathies with an immune component.”

According to the company’s recent release, aTyr previously announced results from a completed Phase 1b/2 open-label, intra-patient dose escalation trial testing doses of Resolaris up to 3.0 mg/kg biweekly in patients with LGMD2B.  Based on the clinical trials completed to date, Resolaris has demonstrated a favorable safety profile without signs of immuno-suppression of circulating immune cells. 78% of the LGMD2B patients in the trial (7 of 9) recorded increases in their muscle function at 14 weeks as measured by manual muscle test (MMT), a validated assessment tool. Overall, the LGMD2B patients had a mean increase of MMT scores from baseline of 6.2%.

“We appreciate the FDA’s responsiveness to our request to remove the partial clinical hold that provides dosing flexibility based on our data for Resolaris,” commented Sanjay Shukla, MD, MS, Chief Medical Officer of aTyr Pharma. “We also believe that during our safety and dose ranging Phase 1b/2 clinical trials we have potentially identified a dose for the next phase of clinical development with a favorable safety profile and potential clinical activity across different rare muscle indications.”

Now commanding a market cap of $55.5M, LIFE has a significant war chest ($34.3M) of cash on the books, which stands against about $2.6M in total current liabilities. The company is pre-revenue at this point. You can bet we will update this one again as new information comes into view. For continuing coverage on shares of $LIFE stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!

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