Natalie Finn, Author at BioTuesdays

Developments

IntelGenx submits response to CRL from FDA for RIZAPORT VersaFilm

IntelGenx (TSX:IGX; OTCQB:IGXT) responded to the complete response letter (CRL) for its 505(b)(2) NDA for RIZAPORT VersaFilm received from the FDA in March 2020. “We have been encouraged by our interactions with...

October 18, 2022

Markets

Canaccord cuts T2 Biosystems to hold on Q3 results and guidance

Canaccord Genuity Capital Markets downgraded T2 Biosystems (NASDAQ:TTOO) to “hold” from “buy” and slashed its price target to $2.50 from $12.50, adjusted for the recent 1-for-50 reverse stock split after the company...

October 14, 2022

Developments

IntelGenx updates atai collaboration as first-in-human study launched of an oral film psychedelic drug candidate

IntelGenx (TSX:IGX; OTCQB:IGXT) updated its collaboration with strategic partner, atai Life Sciences (NASDAQ:ATAI), which has begun a first-in-human Phase 1 study for the development of novel formulations of...

October 13, 2022

Executive Moves

Kumaraguru Raja joins ROTH healthcare research team

Kumaraguru Raja, Ph.D., joined ROTH Capital Partners healthcare research team, as managing director, senior research analyst covering biotechnology. His research coverage is expected to include micro-cap and small-cap...

October 11, 2022

Developments

FDA clears Boston Cell Standards’ IHControls panel in breast cancer

Closely-held Boston Cell Standards received 510(k) clearance from the FDA for its IHControls panel (HER2/ER/PR) for evaluating breast cancers, representing a first-in-category regulatory approval. IHControls are the...

October 6, 2022

Developments

Sigyn Therapeutics files U.S. patent entitled “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity”

Sigyn Therapeutics (OTCQB:SIGY) filed a provisional patent application entitled, “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity,” with the United States Patent and Trademark Office. Cancer is...

October 6, 2022

Executive Moves

Sigyn Therapeutics strengthens board with 3 appointments

Sigyn Therapeutics (OTCQB:SIGY) appointed Richa Nand, Jim Dorst, and Christopher Wetzel to its board, effective Oct. 10, 2022. “As we transition toward the next phase of our clinical endeavors, it is an opportune...

October 4, 2022

Developments

FDA clears Tonix IND in major depressive disorder

The FDA approved Tonix Pharmaceuticals’ (NASDAQ:TNXP) IND application to support a Phase 2 clinical trial with TNX-601 ER, a once-daily formulation of tianeptine as a potential treatment for major depressive disorder...

October 3, 2022

Markets

Stifel cuts PhaseBio to hold on bentracimab ownership dispute

Stifel downgraded PhaseBio Pharmaceuticals (NASDAQ:PHAS) to “hold” from “buy” and slashed its price target to $1 from $15, citing an ownership dispute over PhaseBio’s bentracimab, a potential ticagrelor reversal agent...

September 28, 2022

Developments

atai unit initiates Phase 1 trial for MDMA derivative EMP-01

EmpathBio, a unit of atai Life Sciences (NASDAQ:ATAI), received regulatory and ethics approval to begin enrollment of its Phase 1 study of EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment...

September 28, 2022

Author - Natalie Finn

IntelGenx submits response to CRL from FDA for RIZAPORT VersaFilm

Canaccord cuts T2 Biosystems to hold on Q3 results and guidance

IntelGenx updates atai collaboration as first-in-human study launched of an oral film psychedelic drug candidate

Kumaraguru Raja joins ROTH healthcare research team

FDA clears Boston Cell Standards’ IHControls panel in breast cancer

Sigyn Therapeutics files U.S. patent entitled “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity”

Sigyn Therapeutics strengthens board with 3 appointments

FDA clears Tonix IND in major depressive disorder

Stifel cuts PhaseBio to hold on bentracimab ownership dispute

atai unit initiates Phase 1 trial for MDMA derivative EMP-01

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