Search This Blog

Monday, December 30, 2019

Axsome bull now sees nearly 100% upside

“MOMENTUM Makes Mark,” goes the title of a note from HC Wainwright after positive Phase 3 trial results announced this morning.
The team now sees a 60% chance of approval for AXS-07, up from 30% previously, and lifts its price target to a Street-high $200 from $170. AXSM currently up 4.9% on the session to $106.99.
Presentation slides from this morning’s post-release conference call.

EssilorLuxottica discovers costly fraud at Thai plant

Eyewear group EssilorLuxottica has discovered fraudulent money transfers at a plant in Thailand, which could hit 2019 results by as much as 190 million euros ($213 million).

The news comes as the group formed from the 2017 merger of French lens maker Essilor and Italian glasses company Luxottica conducts a shake-up to unite the supply chains of both companies and reorganise senior management.
The 2017 deal was presented as a “merger of equals” but developed into a row between Luxottica’s founder Leonardo Del Vecchio and Essilor Chief Executive Hubert Sagnieres.
The group has said it aims to appoint a new CEO by the end of 2020, though an activist hedge fund owned by billionaire investor Daniel Loeb has urged the company to “accelerate leadership transitions”.
EssilorLuxottica, known for brands including Oakley and Ray-Ban, said on Monday that its Essilor International business recently discovered fraudulent financial activity in Thailand and that employees suspected of involvement had been sacked.
Shares in the group were down 2.8 percent at 1544 GMT.
“Essilor International filed complaints in Thailand and in other jurisdictions and mobilised all available internal and external resources to put an immediate end to these fraudulent activities and implement remedial actions,” the company said.
EssilorLuxottica added that the negative impact from the Thailand fraud would be recorded in its 2019 operating results.
Luca Solca, a senior research analyst at Bernstein, said that Monday’s news is likely to provoke further investor pressure for speedy post-merger integration.
“Management indicate that the fraud was organised by Essilor’s local management via cash payments to fictitious suppliers in a relatively short amount of time,” Solca added.

Lilly prevails in Alimta patent challenge

An Indiana district court has ruled in favor of Eli Lilly (LLY -0.4%) in a patent infringement case related to lung cancer med Alimta (pemetrexed). Would-be generic competitor Apotex will be prohibited from launching its alternative version until the patent expires in May 2020.
Apotex will likely appeal the decision.

Aridis Pharma up 43% on development of new antibody platform

Ultra-thinly traded Aridis Pharmaceuticals (ARDS +43.3%) is up on a 31x surge in volume, albeit on turnover of only 193K shares, in apparent response to its disclosure that it has developed a monoclonal antibody (mAb) discovery and production technology called APEX that it says maximizes yield.
The mAb discovery platform enables the screening and single-cell cloning of antibody-producing B cells using microarrays, a proprietary cell line technology called BREATH CHO, that enables gene-editing-assisted gene swapping of the candidate antibody genes with endogenous versions that increases cell line productivity.
The company will collaborate with Mapp Biopharmaceutical to develop enhanced versions of an undisclosed number of CHO cell lines originally developed by Mapp using APEX. Financial terms remain confidential.
On the working capital front, at the end of September, it had $17.3M in cash and equivalents while operations consumed $11.8M during the first three quarters of the year.

New FDA food labeling rules required January 1

The FDA issues additional labeling guidance for packaged foods aimed at answering questions from manufacturers who are required to be in compliance with the new rules when 2020 begins (applies only to companies with at least $10M in food sales). Key points:
Nutrition Facts for foods that can be reasonably consumed in one meal or snack are presented in two columns, one based on a single serving and the other based on the contents of the entire package. Serving sizes will reflect what people actually eat and drink, not a recommendation of what to consume (a big change for snack foods).
In the spirit of cooperation, the agency will not prioritize enforcement actions for six months to allow everyone to get on board. Companies with less than $10M in food sales will have an additional year to comply.
Selected tickers: Nestle (OTCPK:NSRGY -0.8%), Kellogg (K -0.4%), General Mills (GIS -0.6%), Mondelez International (MDLZ -0.1%), Farmer Bros (FARM +2.6%), G. Willi International (WILC -1.7%), Sanderson (SAFM -0.3%), Pilgrim’s Pride (PPC -1%), Pepsico (PEP -0.4%), Coca-Cola (KO -0.3%), Tyson Foods (TSN -1.2%), Kraft Heinz (KHC +0.3%), Conagra Brands (CAG -0.2%)

Auris forms new unit focused on tinnitus and hearing loss

Auris Medical (EARS +12.2%announces a new subsidiary, Zilentin Ltd., under which it will bundle its development projects in tinnitus (ringing in the ears) and hearing loss. The unit will be domiciled in Zug, Switzerland.

Chinese scientist gets three years in prison over genetically engineered babies

A Chinese court has sentenced He Jiankui to three years in prison for violating regulations and ethical principles when he and two colleagues edited the DNA of twin IVF embryos to make them resistant to the HIV virus then implanted them in an HIV-negative woman who subsequently gave birth to twin girls in 2018. The father was HIV-positive.
The case caused an international uproar because he performed the procedure with CRISPR/Cas9, still highly experimental, without regulatory approval and oversight which the scientific community regarded as profoundly reckless and unethical.
Selected tickers: CRISPR Therapeutics (CRSP -5.6%), Intellia Therapeutics (NTLA -2.7%), Editas Medicine (EDIT -2.7%)